Following the publishing of draft guidance on cyclosporine by FDA, ophthalmic specialist Allergan is requesting that FDA revise its guidance on cyclosporines, arguing that generic versions of its eye drug Restasis (cyclosporine ophthalmic emulsion) should be tested in humans before approval, not just in a laboratory.
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Generics
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- US generics launch and approval for Dr Reddy’s and Lupin
- Five Chinese companies join UN’s MPP for Covid-19 medicines
- South Korean companies to make generic Bridion and COVID-19 drugs
- Revlimid (lenalidomide) generics launch across Europe
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Biosimilars
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- New insulin glargine and potential adalimumab interchangeable biosimilars
- Biosimilar advances for Alvotech-Teva and setback for Biocon Biologics
- Advances for Bio-Thera’s secukinumab and mepolizumab copy biologicals
- FDA and EMA file acceptance of Biogen’s tocilizumab biosimilar
Research
- US vs Germany and Switzerland: US biosimilars market lags with higher prices
- Drug survival of adalimumab biosimilars in psoriasis treatment in Spain
- Pegfilgrastim biosimilars in US supportive oncology
- Investigating cell, tissue and gene therapy products and their regulation
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